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The Rhythm of Management: What Jazz Can Teach Startup Executives

Mon, 09/15/2014 - 09:26
Jeff Erramouspe

“Jazz stands for freedom. It’s supposed to be the voice of freedom: Get out there and improvise, and take chances, and don’t be a perfectionist – leave that to the classical musicians.”
— Jazz great Dave Brubeck

Playing in a jazz ensemble and leading a business are very, very similar. And my experiences both as a jazz fan and a trumpet player have had a significant influence on my philosophies as an executive, currently as the CEO of Austin’s Spanning Cloud Apps.

But jazz and management? Similar? Allow me to explain.

Jazz is one of the more misunderstood musical genres. To the casual listener, it sounds like a cacophony of improvisation without a framework, where everyone is doing their own thing. Mind you, it’s a broad genre which can run the entire gamut—from straight blues and “hard bop,” perhaps two of the easier forms to understand, to more complex “fusion”—literally, the conjoining of jazz and rock, to even more complicated forms, like the seemingly unstructured work of Sun Ra and his Arkestra. Yet even that is built around a foundation, and all of this is relevant for leadership.

I grew up around music. My dad was a high school band director and music teacher, and I was a trumpet player who spent my younger years playing jazz—good enough that I was actually paid to play while in high school. Music was a big part of my life growing up. That is, until college, when I found economics and business to be more to my liking. As I moved from the world of jazz to the world of business, one thing I recognized is that two aren’t as divergent as one might first believe. There are tremendous similarities between great jazz and great organizations.

Even the most “free-form” of jazz has a framework that allows each musician the freedom to push boundaries through improvisation while staying within pre-set parameters in order to create excellence. I’d like to cite three classic albums that, despite their inherent differences, truly illustrate my point.

First is John Coltrane’s “Blue Train”, the first solo record, and a masterpiece, from one of the greatest alto sax players of all time. The listener’s first reaction: “This is something special.” And it was, because Coltrane wasn’t afraid to surround himself with the best talent. He purposefully identified up and coming “employees” and gave them critical roles in executing his vision. On this historic album, the onetime Miles Davis sideman included musicians that would go on to serve as Davis’ bandmates as well as members of Art Blakey’s Jazz Messengers. The management lesson here? Take your time to find extraordinary talent, and then nurture it. This certainly isn’t exclusive to the genre of jazz, mind you, but it is an important lesson—in music and management.

Next up is Dave Brubeck’s “Time Out”, the artist whom I quoted at the start of this piece. The album is challenging yet catchy. And this is because Brubeck was messing around with complex time signatures—such as 9/8 and 5/4—that were atypical in music composition. And it became a huge hit—peaking at #2 on the Billboard album chart and becoming the first Recording Industry Association of America (RIAA)-certified platinum jazz album. So while the song constructions were unorthodox, the end result was a huge success and is considered a modern-day classic. The management lesson here? Take chances, and challenge the status quo.

Finally, the controversial Miles Davis’ “Bitches Brew,” the album that literally created a new sub-genre of jazz: fusion. Listeners were perplexed, to say the least. According to jazz critic Bill Meyer, “With the release of the original double LP, Miles Davis drew a line in the sand that some jazz fans have never crossed, or even forgiven Davis for drawing.” Yet others praised it as a masterpiece and the beginning of new opportunities for jazz. The management lesson here? Take the one from Dave Brubeck, and multiply it by 10: Don’t just challenge the status quo. Set the new standard for others and push employees to try new things and explore unchartered waters. The results may not always work the first time, but they just may. Purists were confused by “Bitches Brew,” but it opened Davis up to an entirely new audience and became his first gold record.

So are jazz and management different? Yes … and no. If you provide a solid framework of trust and give your employees the tools to both innovate and succeed—and aren’t afraid of a few negative reviews from “purists” now and then—you can truly draw a straight line between the two.

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Innovation Hub: Why Tech’s Women Problem Is Bigger Than You Think

Fri, 09/12/2014 - 15:42
Kara Miller

You’ve seen the numbers. And they’re not good.

At Apple, Twitter, Google, and Facebook, women are vastly outnumbered by men. When it comes to technical positions like coders, men occupy 80 to 90 percent of the positions. Which isn’t a great sign if these represent the jobs—and skill sets—of the future.

The startup scene is also dominated by men, and most studies show that fewer that 5 percent of venture capitalists are women.

So what does it feel like as a woman in the tech trenches? And how do we address the problem?

I talked with venture capitalist Eurie Kim, Principal at Forerunner Ventures, and Sheri Atwood, CEO of SupportPay. Here’s a taste of our conversation:

[This interview has been edited and condensed. For the full conversation, visit innovationhub.org.]

Kara Miller: Sheri, there’s been a lot of media coverage of this issue. But what is your day-to-day experience like as a woman in the tech world?

Sheri Atwood: Well, there has been a lot of media coverage. Unfortunately, it is sort of true. There are definitely events that I go to, and it’s mostly men. Actually, mostly young men, probably under the age of 25. But it also shows me the huge opportunity for women to build companies with problems that are not being addressed today.

Kara Miller: Eurie, in your view, what’s going on? Why are there not women in the pipeline for tech jobs?

Eurie Kim: It’s so frustrating because you would love to believe that we could get the girls early enough, if that means you have to go to high school and get them involved in science and math classes. Or if it goes back even further to 3rd or 4th grade, but I personally feel like that’s what we end up having to do. There are a lot of side educational companies that are popping up where you can learn how to code, and I think that the more that parents can encourage their daughters to get involved in that—to think it’s fun—that’s the starting point of it all.

Sheri Atwood: I absolutely agree with that, and I think that the fundamental problem is being a coder or a developer or doing engineering or technology is simply not seen as being cool for girls. I have a 10-year-old daughter, and I can certainly say that she’s excited because in her computer science class, she gets to say that her mom codes and develops. But mostly it’s the boys and the dads that are talked about.

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West Coast Biotech Roundup: Gates, Orexigen, Medivation & More

Fri, 09/12/2014 - 08:30
Alex Lash

The West Coast news of the past seven days was dominated by approvals. The FDA was responsible for two of them.

In San Diego, Orexigen Therapeutics traveled a long, long road with its weight-loss drug Contrave, and finally saw the FDA’s green light. But apparently investors didn’t approve; they threw the company’s stock price into reverse the next day. In San Francisco, Medivation won a label expansion for its prostate cancer treatment Xtandi. A far more satisfying approval was for the life’s work of University of Washington geneticist Mary-Claire King, who received one of the world’s top scientific honors from the Lasker Foundation. Previous winners Bill and Melinda Gates also made news—or more precisely, their eponymous foundation did, releasing $50 million to combat Ebola. With your approval, let’s move on to the roundup.

—On Wednesday the FDA approved Contrave, a weight-loss drug from Orexigen (NASDAQ: OREX) of San Diego. Contrave combines two drugs, already approved for other uses, in an extended-release formulation. The FDA designated Contrave for people who are obese or overweight with at least one weight-related health condition, following an approval process that took over four years. Despite the green light, the company’s share price fell nearly 11 percent Thursday. TheStreet.com’s Adam Feuerstein goes through some of the possible reasons here.

—After a swift review, San Francisco’s Medivation won a second approval for its prostate cancer treatment enzalutamide (Xtandi), which it co-owns with Japan’s Astellas Pharma. Enzalutamide, which is taken as a pill, first got the FDA’s nod in 2012 to treat patients with metastatic castration-resistant prostate cancer who had already undergone chemotherapy. The agency said Wednesday it can now be used to treat the same cancer but before chemotherapy—a much bigger population than the drug was previously approved for. Johnson & Johnson’s abiraterone (Zytiga) is the other oral prostate cancer drug on the market. A third is being developed by Tokai Pharmaceuticals, which is in line to go public, as we reported here.

—The Bill and Melinda Gates Foundation of Seattle announced Wednesday $50 million in emergency funds for the Ebola crisis in West Africa. The cash is to be distributed to health organizations and governments in the affected countries for emergency supplies and operations, as well as to groups conducting R&D for drugs, vaccines, and diagnostics. The amount for each has not been determined, but the foundation has already committed $5 million to the World Health Organization, $5 million to the U.S. Fund for UNICEF, and $2 million to the U.S. Centers for Disease Control. The Gates money adds to the public and private sector activity to create more therapeutic options to fight Ebola, which has ramped up in recent months in a mixture of grants and incentives, as Xconomy reports here.

—University of Washington geneticist Mary-Claire King won the 2014 Lasker-Koshland Special Achievement Award, one of the Lasker Foundation’s annual science prizes. King is being honored for a range of work, including the research that helped pinpoint the breast cancer gene BRCA1, and DNA work to find the “disappeared” victims of the Argentinian military dictatorship of the 1970s and 1980s. King will accept the award in New York September 19.

—Researchers at the UC San Diego School of Medicine have begun recruiting 40 patients for a first-of-its-kind clinical trial of a stem cell-derived therapy for patients with Type 1 diabetes developed by San Diego-based ViaCyte. The California Institute for Regenerative Medicine has provided … Next Page »

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How to Attract Smart People, Smart Ideas, and Smart Money

Fri, 09/12/2014 - 07:00
Joan Siefert Rose

North Carolina entrepreneurs are attracting attention all over the nation—and all over the world—across the tech, life science, and advanced materials sectors.

The proof is in the numbers.

Last year, more than 220 entrepreneurial companies in North Carolina raised nearly half a billion dollars through equity investments, grants, and awards from 108 unique funders, according to our Innovators Report, a semi-annual publication tracking startups and entrepreneurship in the state. The report focuses on three major indicators: investments, partnerships, and exits, and the biggest news was that 75 percent of these funders were from other states or other countries. We had investors from New York and Boston, California, Atlanta, and Chicago, as well as about a dozen international funds.

Furthermore, 80 percent of the money raised for entrepreneurial companies in North Carolina was invested right here in the Triangle (Wake, Durham, and Orange counties).

As president of the Durham, NC-based Council for Entrepreneurial Development (CED), the largest and oldest entrepreneurial support organization in the country, I often get asked: How do these deals come together?

Consider the stories of three entrepreneurs attracting attention (and investments) in the state of North Carolina and beyond:

Phononic

With a Ph.D. in organic chemistry from the University of Southern California and an MBA from New York University, Tony Atti spent a decade in New York City brokering deals for a venture capital fund. He started Phononic in 2008 with some proprietary technology from the University of Oklahoma and concepts on a whiteboard. Phononic’s big idea is applying semiconductors for cooling and heating that eliminate the need for compressors; think of a refrigerator that’s silent and sustainable (freon and electricity need not apply).

Phononic raised its first money from private investors in 2009, followed by a competitive grant from the federal government designed to encourage innovation in energy efficiency. Tony moved his “virtual” company to the incubator at Centennial Campus at North Carolina State University in 2010. Why did he choose Raleigh? Because of the talent—he needed smart engineers with expertise in semiconductors and manufacturing. He told me that came down to just a handful of places—and Raleigh had the workforce, the quality of life, a good business climate, and the specialized network he needed. Looking back, Phononic convinced two of Silicon Valley’s most well known VCs to build a semiconductor hardware company … in North Carolina.

The Great Recession barely slowed Phononic down at all. The company proved its technology worked, and raised $17 million in venture capital. Soon after came a deal with the world’s largest appliance manufacturer, thanks to an introduction made through the North Carolina Department of Commerce. A move to a manufacturing facility at the edge of Research Triangle Park followed, along with $26 million in expansion investment from funds in California and China. The company just completed work on a 20,000-square-foot manufacturing facility that will employ 60 people in good-paying manufacturing jobs with growth on the horizon.

Phononic continues to evolve. Now a full-fledged consumer products company, it is introducing new products for medical and lab refrigeration, and is poised to deliver thermal management solutions for climate control, cooling big data and server units, and other applications under development.

BioMason

Ginger Dosier is all about bricks. But not the type you and I grew up with. Dosier grows bricks through a process using microbes with the unique ability to produce cement. Her company is called BioMason, and she started down the path of entrepreneurship while teaching architecture at North Carolina State University.

Dosier says she became interested in bricks while in architecture school. Because they’re simple to make, they are used all over the world. But traditional bricks need clay, and have to be fired at high temperatures—both of which are harmful for the environment, especially as demand picks up in rapidly growing countries.

About eight years ago, she started taking courses in biology and chemistry and talking with scientists. She particularly wanted to explore whether building materials that occur in nature—coral reefs, seashells, spider webs—could be models for more environmentally friendly building materials.

This led to several years of experimentation using sand and a variety of organic mixtures with bacteria that have the ability to turn sand into sandstone. For a couple of years, she used a spare bedroom in her Raleigh apartment as a lab.

Through a lot of trial and error, Dosier happened upon … Next Page »

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After Prolonged Review, FDA Approves Orexigen’s Weight-Loss Drug

Wed, 09/10/2014 - 22:52
Bruce V. Bigelow

The FDA today approved a new weight-loss drug for people who are obese or overweight with at least one weight-related health condition, easing a burden that San Diego’s Orexigen Therapeutics (NASDAQ: OREX) has been carrying for a long time.

Orexigen experienced several setbacks while advancing the drug, an extended release formulation of two previously approved drugs, naltrexone and bupropion, which the company plans to market with Japan’s Takeda Pharmaceutical as Contrave. Naltrexone is an opioid blocker approved in 1984 for treating drug addiction, but now used primarily for alcohol dependence. Bupropion is a widely used antidepressant and smoking cessation drug.

It is Orexigen’s first drug approval, and the third obesity drug approved by U.S. drug regulators since 2012.

The company initially submitted its new drug application to the FDA in early 2010, and an FDA advisory panel gave its OK in a 13-7 vote at the end of that year. But the biopharmaceutical company said it was shelving the program in mid-2011, after the FDA  told Orexigen it would have to conduct a long-term clinical study of more than 60,000 patients to determine if Contrave posed a risk for heart attacks and other adverse cardiovascular events.

Work resumed, however, after Orexigen later proposed a cardiovascular study that would draw on existing data from almost 10,000 patients who had participated in a late-stage trial of Contrave. The company revised the application for Contrave and finally submitted it at the end of 2013. Trading in Orexigen shares began to climb as investors anticipated final regulatory approval in mid-June. Instead, there was more delay: the FDA extended its review to refine details of Orexigen’s post-marketing obligations for a continuing assessment of the drug’s potential cardiovascular risk.

In its statement today, the FDA says it has cleared Orexigen’s pill as another treatment for people who are obese or overweight and who have type 2 diabetes or a similar weight-related health condition. The agency says the drug is intended to reduce appetite and control cravings, and should be prescribed as part of a healthy lifestyle regimen that includes a reduced-calorie diet and exercise.

Contrave is the third weight-loss pill to hit the market in the last two years, and will compete against lorcaserin HCL (Belviq), co-marketed by San Diego-based Arena Pharmaceuticals (NASDAQ: ARNA) and Japan’s Eisai, and the combination of phentermine and topiramate that Mountain View, CA-based Vivus sells as Qsymia.

Arena’s Craig Audet said he welcomes the competition. “There’s so much room for growth here that we don’t have to go after each other in terms of market share,” said Audet, who is Arena’s senior vice president of operations and head of global regulatory affairs.

Almost 79 million American adults are obese, a condition that carried $147 billion in medical costs in 2008, according to the Centers for Disease Control and Prevention. Yet only 2 percent of the people who meet the treatment criteria as obese or overweight are being prescribed weight-loss drugs, Audet said.

With more Orexigen sales reps promoting the benefits of Contrave, Audet said he anticipates greater public awareness as a growing number of voices calling for improved weight-loss care. He also expects physicians will become more attuned to the particular strengths and weaknesses of each drug.

The FDA approved Contrave for obese adults with a body mass index (BMI) of 30 or greater or overweight adults with a BMI of 27 or greater who have at least one weight-related health condition.

Orexigen said late today it has scheduled a conference call and webcast at 8:30 am ET Thursday for top executives to talk with investors and analysts about what happens next.

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Avelas Closes Round, Advancing Biologic That Illuminates Breast Cancer

Wed, 09/10/2014 - 09:00
Bruce V. Bigelow

San Diego’s Avelas Biosciences, which is developing a fluorescing peptide to illuminate cancerous tissue during breast surgery, says today it has closed the second tranche of its Series B round, bringing total funds raised in the round to $7.4 million.

Avelas says the capital will be used to move toward a first-in-human study in breast cancer surgery patients for AVB-620, an in vivo fluorescent protease-activated peptide that is its lead product candidate. The company says AVB-620 is expected to enter clinical studies later this year.

Protease activity is high in tumors and metastases, so a peptide that glows in the presence of high protease activity can be used to differentiate healthy tissue from cancerous tissue. The technology was developed by Roger Tsien, a biochemist at UC San Diego who shared the 2008 Nobel Prize in chemistry for his role in the discovery and development of green fluorescent protein.

Roger Tsien with tubes of fluorescing peptides (courtesy Tsien lab/UCSD)

Tsien founded Avelas in 2009 with Kevin Kinsella, the founder of San Diego-based Avalon Ventures.

Avelas says AVB-620 would be administered to patients intravenously before surgery. A fluorescence imaging camera system can then be used during surgery to light up cancerous areas and help surgeons decide what tissue should be excised. In preclinical testing, the accuracy of AVB-620 in the body is better than 95 percent, according to the company.

San Diego’s Avalon Ventures participated in the latest venture round, along with existing investors Torrey Pines Investment, WuXi PharmaTech Investments, and other unnamed investors.

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An Intriguing Program Takes on Tropical Diseases—But Not Ebola

Wed, 09/10/2014 - 07:30
Alex Lash

[Updated and corrected 9/10/14, 10:05 am. See below.] On August 28, Anthony Fauci, the U.S. National Institutes of Health’s top infectious disease specialist, announced a major trial in concert with GlaxoSmithKline (NYSE: GSK) to test new Ebola vaccines in humans. Fauci called it an “all-hands-on-deck response” to the growing global health emergency in which more than 2,000 people have died in West Africa.

Plenty of other weapons are being marshaled, too, but in the fight against Ebola, the U.S. government’s quiver is at least one arrow short. Since 2007, a relatively little-known financial incentive program has been in place to encourage the private sector to develop medicines for neglected tropical diseases. Companies that bring a treatment to market for such a disease receive a priority review voucher to apply to any drug in their pipelines. It’s an intriguing carrot to dangle: cutting a few months from the review process of a potential blockbuster drug can mean tens, perhaps hundreds, of millions of dollars in extra sales if it’s approved.

Bill Gates, speaking in Davos, Switzerland in 2008, was a fan of the idea: “I believe the highest-leverage work that governments can do is to set policy to create market incentives for business activity that improves the lives of the poor… If you develop a new drug for malaria, your profitable cholesterol-lowering drug could go on the market a year earlier.”

[UPDATE: The Gates Foundation announced Wednesday $50 million in emergency relief funds to fight Ebola. An undetermined portion of those funds will go toward R&D for drugs, vaccines, and diagnostics.]

While the voucher program has its flaws, it reached an important milestone this summer: the first sale of a voucher from one drug company to another, establishing a secondary market for those who don’t want to apply the voucher to their own pipeline.

Sixteen tropical diseases qualify a company for the program, including some of the world’s biggest scourges: tuberculosis, malaria, cholera, and dengue fever.

But when lawmakers drew up the list seven years ago, Ebola did not make the cut. It’s never been a widespread killer like many others on the list, and it’s not on the World Health Organization’s list of neglected tropical diseases, either. (“There is no hard-and-fast definition of neglected diseases, but they tend to be persistently present in low-income countries and populations, whereas Ebola is an epidemic disease that only breaks out rarely,” according to WHO spokeswoman Donna Eberwine-Villagrán.)

A healthcare worker analyzes tissue samples in a mobile lab in Guinea. (Credit: WHO/Stephane Saporito)

But the list of diseases eligible for the voucher program differs from WHO’s list in other ways as well (malaria isn’t on the WHO list, for example). And besides, modern population movement and Ebola’s virulence, killing more than half of those it infects, make Ebola’s exclusion from the voucher list puzzling.

“It really should have been included,” BIO Ventures for Global Health president Jennifer Dent tells Xconomy.

In an op-ed published last month in the Seattle Times, Dent wrote, “The current, conventional drug-development approach does not work when it comes to creating treatments for rare and uncommon diseases like Ebola.” She called for “a new paradigm” of cooperation and coordination between the public and private sectors. We’re seeing that cooperation to some extent in a recent spate of news, including Fauci’s August 28 announcement, about programs ramping up quickly.

One could argue whether the action has been fast enough. The outbreak was first detected in March, after all, and WHO outlined one scenario in late August in which the outbreak could run nine months and … Next Page »

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Xconomy Q&A: Intellectual Ventures Co-founder and CTO Edward Jung

Wed, 09/10/2014 - 00:56
Benjamin Romano

Edward Jung, co-founder and chief technology officer, of Intellectual Ventures, has been out talking about how his company—which was recently described as among Silicon Valley’s most hated—is playing a long game to attack the big problems confronting the world today.

On the sidelines of the Boao Forum for Asia in Seattle last week, Jung sat down with Xconomy to talk about how he handles the fire hose of ideas he encounters each day, Asia’s trapped innovators, and where the company, based in Bellevue, WA, is headed now. It recently cut its staff of 700 by about 20 percent.

Jung had just come from a panel discussion at the event focused on U.S.-China relations featuring Bill Gates; Nathan Myhrvold, one of Jung’s IV co-founders; former U.S. Treasury Secretary Hank Paulson; and China’s former ambassador to the United States, Zhou Wenzhong. Their conversation highlighted the kind of huge, intractable global problems that governments—run by officials concerned with the next election, not the next generation—are ill suited to solve, such as climate change. Zhou at one point noted that China will need to import one billion tons of coal over the next 20 years, which left me wondering whether all the energy innovation espoused (and funded) by Gates and Myhrvold would make a lick of difference.

I asked Jung for his reaction, and much more. The following interview has been edited and condensed for clarity.

Edward Jung: I’m very optimistic about the world. The world today is full of optimists. The question is how can you unite them well. And, I think all the basic fundamentals—the innovation happening, the kind of funding that’s available—are acknowledgement of the problems. How you actually weave it together into something that’s actually likely to work, that’s much less clear.

Over the last 40 years what we’ve gotten really good at—your journal covers this quite well—is that if there’s a problem that could be solved by a well-funded company or maybe a small ecosystem of them, we’re really good at doing that now. Compared to about 40 or 50 years ago, you just couldn’t do that.

Now it’s been so mastered, and now it’s trying to be replicated all over the world. Everyone wants to build a Silicon Valley. That model’s well-known.

But now we also recognize that it can’t solve all the problems. So we now are challenged as a species to step up to the next set of things.

There were several times that the panelists were alluding to this notion that the problems are hard. That’s because the easy ones we’ve figured out. When you do that, the only ones that are left are the hard ones. So we shouldn’t be surprised that they’re the ones that government is not adapted to, and that companies aren’t adapted to, and the funding environment is not adapted to, because all the ones those were adapted to, we’ve knocked them down.

Xconomy: You have such a unique job and I’m sure you have a different day every day, travelling around the world. But what does a typical day look like for you, and particularly given what I assume is a massive flow of ideas that you are constantly encountering, what are some of the tools you use to keep yourself in mind of what innovation truly looks like?

EJ: Maybe I’m hoping—but also fearing—[for] the day when I do have a typical day.

One of the things that’s been fascinating about the whole experience with Intellectual Ventures is we’re making a lot of stuff up as we go along. The very business model and trying to approach it at the scale we do and in the manner we do it—there is no textbook to read about it. There’s no course at Wharton that says here’s the case studies that show you how to do this. You’re out there at the front. You’re the explorer. Explorers often get eaten. So you have to be a little careful as you go there, but we’re constantly taking risks and trying new things and learning.

My daily life is looking at the things we’ve done, analyzing how well they’re working, and then figuring out what we need to change. It’s a bit different than if you were in a manufacturing company where you optimize and analyze the stuff you’re doing, but you don’t sit there and keep fundamentally changing it. That would be very disruptive. And it’s a little bit different than say when you’re doing a movie production, where you have a year or two and you’re doing your movie, and then you’re done, and you could do it totally differently the next time if you wanted to. We’re somewhere in between. And I think that’s kind of fun. We have the context of doing it over a long period of time, because our funds are long-dated, and that gives us the flexibility to try these experiments, whereas if we were a typical startup and had to go raise money again every year, it’d be very difficult to change directions that way.

How do you manage it? I haven’t found any tools that are really good at it. Obviously, search is really helpful, and search over your own stuff now. But at the end of the day, I think a lot of it is just processing it in your head. And sticky notes.

X: Where are you finding valuable innovation today that you weren’t a decade ago? … Next Page »

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After Restructuring, SGB Raises $11M for Jatropha Commercialization

Tue, 09/09/2014 - 18:31
Bruce V. Bigelow

San Diego-based SGB, the agricultural biotech previously known as SG Biofuels, says today it has raised $11 million in a Series C round of financing that will be used to drive its revised commercialization strategy.

Existing investors, including Thomas, McNerney & Partners, Finistere Ventures, and Flint Hills Resources (a refining subsidiary of Koch Industries) participated in the round, which brings total venture funding for SGB to almost $38 million.

The company was founded in 2006 as Super Green Biofuels to advance the Jatropha plant as a sustainable energy crop. The idea was to produce high-quality crude oil (for transportation fuels) at low cost, using elite cultivars and biotechnology to maximize the amount of oil that could be extracted from the walnut-size seeds of Jatropha, a hardy, non-edible bush native to Central America.

A strategic restructuring and job cuts preceded the infusion of fresh capital, according to Miguel Motta, who joined SGB in 2010 and was named chief operating officer in 2012.

Kirk Haney, who oversaw the company’s initial strategy, stepped down as CEO several months ago, but has kept his seat on SGB’s board. Concurrent with the Series C funding, the board named Arama Kukutai, a managing director at San Diego’s Finistere Ventures, as executive chairman and appointed Motta president and COO.

In April 2013, Haney told me the company had the full-time equivalent of 57 employees. That number is now about 45, Motta says.

“The key reason why the capital raise was successful is because of the tremendous progress we’ve been making with the technology,” Motta says. Over the past five to seven years, SGB has developed Jatropha strains capable of producing 300 gallons of oil per acre in the first year after planting. Initially, production was about 40 to 60 gallons per acre after four or five years, Motta says.

“Our scientific and breeding teams have cracked the code, and the technology is now ready for full-scale commercial deployment of Jatropha,” Kukutai says in a statement today. “The financing underscores that Jatropha has risen from the ashes and will be a major plantation crop and viable alternative to palm and soybean as a sustainable source of oil and protein.”

As part of its revised strategy, though, SGB has moved to diversify its market opportunities. For example, Motta says SGB now sees Jatropha not only as an oil seed product for energy, but as a source for specialty chemicals, for protein in animal feed and certain non-food applications, and as biomass that can be burned to generate electricity.

The company also has moved to operate more efficiently, chiefly by focusing on its existing production and field trial activities in Central America and India. Motta says the company also is in discussions to expand into Southeast Asia. SGB no longer operates a 42,000-square-foot greenhouse in San Diego, and SGB research and development is now focused in Guatemala, Motta says. The company’s headquarters is still in San Diego.

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FDA OKs Astute Medical’s First Diagnostic for Acute Kidney Injury

Mon, 09/08/2014 - 21:11
Bruce V. Bigelow

San Diego-based Astute Medical, founded in 2007 to identify and validate protein biomarkers that can be used to improve the diagnosis of high-risk medical conditions, says the FDA has cleared its new test for detecting acute kidney injury (AKI).

In a statement Friday, the FDA said the first-of-a-kind lab test can help determine if certain critically ill hospitalized patients are at risk of developing moderate-to-severe AKI in the 12 hours following the test.

The company says its biomarker-based immunoassay, called NephroCheck, will go on sale in coming weeks via a strategic partnership with New Jersey’s Ortho-Clinical Diagnostics. NephroCheck detects the presence of certain proteins (insulin-like growth-factor binding protein 7 and tissue inhibitor of metalloproteinases 2) in the urine that are associated with acute kidney injury.

Astute says NephroCheck is the only diagnostic test available in the United States to assess the risk of AKI, which is characterized by a sudden decline in kidney function, which often begins without symptoms while a critically ill person is hospitalized for trauma, major surgery, infection, or some other condition. Current laboratory tests only assess whether a patient already has AKI. NephroCheck provides a score based on the amount of the proteins present that correlates to the patient’s risk of developing AKI within 12 hours of the test being performed.

“It’s really a severe condition, and things could be twice as bad if you develop it,” says Astute co-founder and CEO Chris Hibberd. Hospitalizations last twice as long, on average, for patients who develop AKI, and their healthcare costs are typically more than double, Hibberd said. Hospital re-admissions occur twice as frequently for AKI patients and the one-year mortality rate also is about double for AKI patients.

Astute Medical’s diagnostic test represents the first real improvement in renal testing in over 60 years, Hibberd says.

Of 5 million patients admitted to hospital intensive care units in the United States each year, Astute says roughly half will develop moderate to severe AKI. Calling acute kidney injury “the most deadly … Next Page »

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John Maraganore: From “Prototypical Geek” To Canny Alnylam Chief

Sun, 09/07/2014 - 01:01
Ben Fidler

John Maraganore opened up an envelope in 1994 that changed his life. Inside were the results of the pivotal study of an anticoagulant drug Maraganore had created in the lab. It was the star prospect for Maraganore’s employer, Biogen. If the drug, bivalirudin, worked, Biogen might have its first product—and Maraganore, the glory of designing it.

The news, however, was bad. Bivalirudin failed the study. Biogen jettisoned the drug altogether, and moved on to become the world’s leader in multiple sclerosis treatments.

And Maraganore, the classic geek scientist obsessed with basic research, would never work at the lab bench again. Instead, Biogen leadership forced him down a new path, one that would transform him into a successful biotech business executive. He would authorize strategic decisions, weigh multi-billion dollar deals, handle the fates of hundreds of employees—and even find a way to bring bivalirudin to market. And ultimately, he would become one of the driving forces behind a new, high-risk, and high-reward, field of science—RNA interference (RNAi)—that aims to “silence” disease-causing genes.

Indeed, 20 years later, Maraganore now is synonymous with RNAi. He’s the CEO of Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ: ALNY), which has grown from fledgling startup to the biggest RNAi operation in the world.

And soon, another crucial envelope is coming for Maraganore. After burning through more than $600 million of invested dollars and enduring a series of highs and lows, Alnylam is running its first Phase 3 trial, with a drug called patisiran. The drug treats a rare condition that causes proteins to clump up in the body and stifle organs. Successful results will turn Alnylam from an expensive 13-year-long science project into a real revenue-generating pharmaceutical company with many more opportunities—and help validate the whole field of RNAi.

If patisiran fails? The chorus of those who doubt RNAi will grow louder.

“That’s fine,” Maraganore says. “That’s just the price of leading an effort.”

Indeed, Maraganore has never played it safe. He could have followed the path of his father and brother, and become a doctor with a stable income. He chose high-risk research instead. He could’ve stayed at Biogen, or later, Millennium Pharmaceuticals—established, stable drugmakers. Instead, he chose to lead a tiny startup pursuing a new field of science. He could have kept quiet when Novartis backed out of RNAi research earlier this year. Instead, he publicly blasted Big Pharma and criticized its ability to innovate.

Kevin Starr

“John is very much not risk-averse. That’s always been his MO as a scientist—he was a very bold scientist,” says Third Rock Ventures partner Kevin Starr, a longtime friend of Maraganore, a colleague at Biogen and Millennium, and a fellow Alnylam boardmember. “Alnylam has survived because he’s looked at it as one of his children and he’s put all that passion in there.”

Still, Maraganore is unfailingly self-effacing. He’s quick to point out his failures (there’s been “tons,” like deals he decided against that burned him down the road) or weaknesses (like running the day-to-day operations of a company). He’ll often point out others who are more qualified than he is to do a job—even if, in potential merger discussions, that may cost him his own. He’ll promote people past him. Starr, for instance, started out as his employee, but became his boss after a promotion Maraganore endorsed. He loves travel and good food, a glass of wine and a cigar, and a game of pool.

“John’s a fun guy,” Starr says, ”[and] he’s been successful by being a giver.”

And by pursuing his passions despite the risks. Maraganore (pronounced mare-a-ga-NOR-ee) was born in 1962 in Chicago, the son of two Greek immigrants and the second of three children. The family started out in a 2-bedroom townhouse in Rogers Park, on the far north side. When Maraganore’s father’s career as a pathologist took off, they were able to move to the upscale suburb of Skokie when Maraganore was about eight years old.

Much was expected of Maraganore and his older brother and younger sister. “We were driven to do important things,” he recalls. If he got an A at school, his parents wanted to know why wasn’t it an A+. Get a B? God forbid. It was tough on Maraganore, because school didn’t come easy to him, as it does for some of those kids that can slack off and ace a test.

“They held you to high standards, and they were hard drivers. It was all around, ‘you need to do better, you need to work harder,’” he says of his parents. “I had to work like a dog. But it did create a real work ethic in me that I have to this day.”

While he sheepishly acknowledges a “Dungeons & Dragons” phase, Maraganore took on all sorts of additional extra-curricular tasks, like the chemistry club, chess club, and yearbook editor. He finished high school near the top of his class.

Maraganore’s father believed that being a doctor meant stability and a good life, and pushed his children towards medicine. The unspoken expectation, according to Maraganore, was that father and sons would open and run a clinic together. His father would bring things home from his lab for his kids, like a microscope that a young Maraganore became obsessed with. “Propaganda,” Maraganore jokes today.

Maraganore also remembers spending summers as an adolescent working in his father’s pathology lab testing patient samples. He learned a lot of lab basics—pipetting, what to do and not to do with blood—and performed radioimmunoassays (tests to measure, say, hormone levels in the blood) and serum chemistry tests.

“[That was] one of the great things about having a pathologist for a father,” Maraganore says. “It was just a great learning experience.”

Maraganore became a certifiable science geek. His favorite class was biology. He volunteered at his high school biology lab, staying late to set up experiments for the next day, or stocking and maintaining the lab’s saltwater fish tank. He’d visit Chicago’s Museum of Science and Industry and speed to the human biology exhibit. He’d collect water samples from different places and bring them to his microscope to look at paramecia or hydras.

“[I’d] look at the microscope, and sort of look at these little tiny organisms and so forth, or a slide and look at cells, and it’s just fascinating, right?” he says. “It’s so beautiful.”

Maraganore’s brother dutifully became a doctor (a neurologist). But Maraganore strayed from the prescribed path. In his sophomore year at the University of Chicago, intending to study medicine, he began doing basic research in a lab under biochemistry professor Bob Heinrikson. He purified and characterized proteins, specifically snake venom enzymes. He recalls being motivated by the idea of exploring things “nobody else in the world was exploring.”

“Just like I enjoyed it when I was a kid, looking at the microscope, I was doing it as an older kid in a basic research lab,” he says. He began to aim for a career as a university scientist.

He sped through grad school, also at the University of Chicago, getting his PhD in biochemistry in just two years, though he claims it was blind “luck” because of … Next Page »

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Vote (Mostly) Online Feeds Millennials’ Need for One-Click Apps

Fri, 09/05/2014 - 14:58
Jeff Engel

For better or worse, the millennial generation has come to expect instant gratification and the ability to complete almost any daily task with just the click of a button on a smartphone or personal computer.

One activity that, for the most part, has not kept pace with rapid technological advancements is voting. That’s why a group of Madison, WI, tech entrepreneurs has created a free service to allow Wisconsin residents to vote in state elections online—sort of.

Vote (Mostly) Online allows users to quickly verify if they’re registered to vote and, if not, to fill out some personal information on the website—including uploading proof of residency such as a photo of an electric bill—and request an official voter registration form in the mail. Next, the website lets visitors request that an absentee ballot be mailed to them, review biographical information of all the candidates up for election, and click on who they intend to vote for in each race.

Meanwhile, Vote (Mostly) Online, (we’ll call it VMO for short), handles all the back-end grunt work. If someone isn’t registered to vote, VMO will print off, fill out, and mail the registration form to the person, who only needs to sign the document and send it to the clerk’s office in the prepaid envelope provided by VMO. For registered voters, the site will contact the clerk’s office to request the absentee ballot on their behalf. After that, VMO will e-mail users to ensure they received the documents in the mail and remind them to fill out and mail in the ballot—including reminding them who they “voted” for on the website.

Although users aren’t actually voting online, the startup’s co-founders believe they’re easing the process and nudging young people to follow through. It’s not that millennials don’t care about participating in democracy, VMO says on its website, it’s that voting “feels like such a pain, and we’re not used to doing things like going to physical places or working with printers and stamps (snail mail is so 20th century).”

“The biggest thing is the psychology,” says Mike Fenchel, co-founder of VMO and Madison co-working space 100state. “We’re in an age of instant gratification. People like to do something that’s taking an action they enjoy.”

This isn’t the only ongoing effort to bring America’s voting system into the 21st century. San Diego-based Everyone Counts, for example, created a suite of software products to bypass voting machines and paper ballots. The company’s customers include government jurisdictions in the U.S. and other countries. It has facilitated completely online voting for elections in West Virginia, Colorado, and Hawaii, as well as private-sector contests like the Oscar and Emmy awards, says founder and CEO Lori Steele-Contorer.

Her company hasn’t yet been involved in any Wisconsin elections, she says, but she has done some preliminary research and would like to bring Everyone Counts to the Badger State.

VMO, meanwhile, isn’t making any money off of its website, at least for now. Its co-founders volunteered their time to get it off the ground. (Besides Fenchel, the other founders include Niko Skievaski, also a 100state co-founder, and Kyle Pfister and Chris Franson, founders of Ninjas for Health.)

After the pilot in Wisconsin’s November election, VMO is considering licensing the software to political campaigns as a white-label service, who could use it to improve the chances that constituents who express an interest in voting for a candidate follow through, Fenchel says.

“Campaigns and nonprofits have resources to reach out and call voters; they have their lists,” Skievaski says. Having the VMO service “in their bag of tools” could “be powerful for them,” he adds.

Even if the white-label service takes off, the startup plans to … Next Page »

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Innovation Hub: John Maeda on Why Tech Loves Design

Fri, 09/05/2014 - 11:30
Kara Miller

John Maeda stands at the intersection of design and technology—and attracts a bit of a cult following. He’s the first Design Partner at Kleiner Perkins, the venture capital firm that has backed companies from Amazon to Genentech to WebMD. Previously, he served as President of The Rhode Island School of Design.

Maeda insists that design is more crucial to tech companies than most of them realize. I asked him why.

[This interview has been edited and condensed. For the full conversation, visit innovationhub.org]

Kara Miller: Why do you think Kleiner Perkins wanted someone at the firm who focuses on design?

John Maeda: Well, technology used to be the only reason you’d buy a high-tech gadget. You wanted to know what was in it, how big was the screen, and things like that. It used to be that only a few people could make these things. But now everyone can. So design has become a differentiator. It’s the reason you’ll buy something. It used to be you couldn’t get all the megabyes or gigabyes you wanted, and now you can get what you want. The question is: how does it make me feel? How does it make me look?

KM: You’ve talked about design being crucial in the culture of certain companies, like Airbnb. How does that manifest itself?

JM: You might think you walk into a creative organization and you see beanbag chairs and squishy balls…

KM: … And people on skateboards.

JM: Exactly. But instead, it’s a place where creativity matters. It’s where art is part of the culture. It’s where people who are divergent are welcome. And they find a way to take all that and put it into a product. It’s a rare competency.

KM: Do you see a generational shift? With young people valuing design more, either as consumers or producers?

JM: Definitely so. Younger entrepreneurs totally get that design is important, so you’ll see them bringing in a co-founder that’s a designer. Or they’ll bring in a designer with their first 10 employees. I think for the early generation of entrepreneurs, design wasn’t so important. So they’re catching up now.

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How the Fukushima Disaster Made a Name for Nuke Startup Kurion

Fri, 09/05/2014 - 04:00
Martin LaMonica

Nuclear waste startup Kurion went from a tiny company betting heavily on government work to one that overnight became a key supplier to the crippled Fukushima power plant. Having gone through trial by fire in Japan, the company now hopes to sell its waste-removing technology to power plants around the world.

The Irvine, CA-based company this week put into service equipment to clean radioactive strontium from the wastewater used to cool the reactors damaged three years ago at the Tepco-owned power plant in Fukushima. And last week, the Japanese government chose Kurion and two other companies to apply for a government grant program to remove radioactive tritium from the tons of water stored at Fukushima. That’s an important step for the company, says CEO Bill Gallo.

“We believe this (tritium removal) technology is effective not just for Fukushima but all the operating pressurized water reactors around the world because there’s been no technology to deal with it,” says Gallo, a nuclear industry veteran who joined Kurion about a year and a half ago. By isolating tritium and other wastes from the water, power plants can greatly reduce the amount of radioactive material they need to store, he says.

Kurion is something of an odd beast in the world of tech startups. There’s certainly no shortage of nuclear waste in the world—power plants alone have generated hundreds of thousands of tons—but the spending programs for treating wastes are dictated by bureaucratic government agencies, a situation that’s difficult for young companies that need earnings and rapid growth. Kurion’s story shows how picking a difficult problem and finding science to solve it can lead to commercial traction.

In Kurion’s case, investors at Lux Capital decided they could make money by taking a fresh approach to nuclear waste and then began searching for relevant technologies. One of them was a set of inorganic materials that can isolate specific elements from radioactive wastewater more effectively than current methods. (The name comes from a combination of curie—a measure of radioactivity—and ion, or charged atom.) The company took an initial investment in 2008.

Kurion CEO Bill Gallo

When the tsunami hit Japan in 2011 and led to the meltdown of three reactors and tons of radioactive cooling water, Kurion focused all its efforts on providing equipment to plant operator Tepco. The company, which had less than ten employees at the time, supplied equipment—packaged inside a shipping container—that removes radioactive cesium from the water that Tepco circulates through the melted cores to keep them cool.

“When Fukushima hit, it was all hands on deck to deal with this tremendous disaster,” says Gallo. “The events at Fukushima were extremely unfortunate. One of the very small benefits by comparison is that it created a need for quick development and deployment of technologies.”

Since then, the company has expanded into other parts of the nuclear waste treatment process. In 2012 it acquired the assets of GeoMelt, a company with facilities in Richland, WA, that takes isolated radioactive material and vitrifies it, or captures it in glass. Vitrification is considered the best method for storing radioactive wastes but it also works for asbestos, dioxins, and other hazardous materials, says Gallo. The company, which now has 150 employees including contractors, also developed robotic technology to inspect leaks in the reactor vessel at Fukushima power plants and repair them.

The nuclear industry, both for power generation and military weapons cleanup, moves very slowly and is heavily dependent on shifting regulations. But the amount of money spent in nuclear wastes is huge; Gallo notes that a portion of the government-funded cleanup site in Hanford, Washington that Kurion is working at will take 50 years and $50 billions to complete.

There are a number of companies, including H3D in Ann Arbor, MI, that have developed better methods for detecting radioactivity and a handful of nuclear power startups with alternatives to the industry’s prevailing power plant design. Gallo, who has worked in energy and nuclear for more than 30 years, says there’s a role for startups with fresh ideas in nuclear but warns that it’s a challenging environment. “There are many barriers to a small company bringing a product to market because you have to understand the regulatory and safety requirements,” he says. “You can’t get it wrong.”

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West Coast Biotech Roundup: Mapp Bio, Calico, Alder, VentiRx & More

Thu, 09/04/2014 - 14:05
Alex Lash

The past seven days have seen breakthroughs and heartbreaks for West Coast biotech companies. Mapp Biopharmaceutical of San Diego got promising preclinical news about its Ebola drug, then almost immediately got millions of dollars of federal funding to push it quickly into human trials. Up the coast near San Francisco, though, Exelixis’s flagship product returned such bad clinical news in prostate cancer that the biotech let go 70 percent of its staff.

There was a breakthrough therapy designation in San Diego: the FDA gave its coveted nod for expedited development and review to primavanserin, Acadia Pharmaceuticals’ treatment for Parkinson’s disease psychosis. And there was a breakup in Seattle: Bristol-Myers Squibb ended its development relationship with Alder Biopharmaceuticals. A lot more news has broken since our previous West Coast roundup. Let us, ahem, break it down for you.

—As our San Diego editor Bruce Bigelow reported Tuesday, the U.S. Department of Health and Human Services awarded a contract worth up to $42.3 million to help Mapp Biopharmaceutical speed the development of ZMapp, an experimental drug used to treat seven healthcare workers in West Africa, five of whom have survived so far. The contract, issued by the health agency’s Biomedical Advanced Research and Development authority, supports an accelerated development program for ZMapp, with a goal of winning FDA approval. The contract comes just days after Mapp scientists and others published a paper in Nature that showed ZMapp in preclinical testing protected all 18 monkeys given the drug after being infected with a strain of Ebola different than the one responsible for the current epidemic in West Africa. ZMapp has not yet been clinically tested in humans.

—The mysterious Calico has revealed its ambitions to at least one group of people. The biotech startup, backed by Google (NASDAQ: GOOG) and run by all-star management, said Wednesday it would partner with drug maker AbbVie (NYSE: ABBV) on treatments for age-related diseases such as neurodegeneration and cancer. The deal could ultimately include $1.5 billion in total cash coming from both parties and will help Calico build an R&D facility in the San Francisco Bay Area. Calico will begin hiring people “immediately,” it said. Each company will start by contributing $250 million, and another $500 million apiece could come later, although they didn’t say Wednesday what would trigger the additional cash. The companies said in a release that Calico will do the early research, discovery, and clinical work through Phase 2a before handing development duties off to AbbVie. Former Genentech CEO Art Levinson, who is running Calico, resigned from Roche’s board of directors less than 24 hours after the announcement. Levinson worked at Genentech for more than 20 years, starting out in 1980 as a research scientist before climbing through the ranks.

—Seattle-based VentiRx Pharmaceuticals has had a busy week. It announced Tuesday a new round of funding—amount undisclosed—from its venture backers and Celgene (NASDAQ: CELG), the Summit, NJ-based drug maker that holds an option to acquire VentiRx. The option stems from a 2012 deal in which Celgene paid $35 million upfront to provide support for VentiRx’s cancer immunotherapy motolimod in trials for ovarian and head-and-neck cancer. The drug is currently in Phase 2 trials in each indication. VentiRx also said Motolimod has received fast-track designation from the FDA in the ovarian cancer setting in combination with the chemotherapy doxorubicin. Xconomy reported recently that VentiRx CEO Rob Hershberg was tapped to run Celgene’s new Seattle “Immuno-Oncology Center of Excellence.” VentiRx reiterated this week that Hershberg will split his time between VentiRx and the Celgene center, and that Katie Fanning has been promoted from VP of business development and alliance management to chief operating officer. VentiRx also announced that motolimod will be tested in combination with other immunotherapy agents by two New York-based nonprofits, Ludwig Cancer Research and the Cancer Research Institute.

—Acadia Pharmaceuticals (NASDAQ: ACAD) of San Diego said the FDA gave “breakthrough therapy” designation to primavanserin (Nuplazid) for treating Parkinson’s disease psychosis. The company, which develops drugs for neurological and related central nervous system disorders, plans to submit a new drug application for primavanserin to the FDA near the end of this year.

—Exelixis (NASDAQ: EXEL) of South San Francisco, CA said Tuesday that its flagship product cabozantinib, approved to treat a form of thyroid cancer, failed in a Phase 3 trial in advanced prostate cancer. It’s a huge blow to the biotech; it said it would lay off 160 employees, or 70 percent of staff, and take a restructuring charge of $6 million to $8 million as it forges ahead with cabozantinib in trials for kidney and liver cancer. At market close Wednesday, Exelixis shares were $1.90 each, down 54 percent from their position just before the bad news.

—Another West Coast biotech saw its share price drop, but not for a discernible clinical failure. Alder Biopharmaceuticals (NASDAQ: ALDR) of Bothell, WA, said Monday that New York-based development partner Bristol-Myers Squibb (NYSE: BMY) was returning all rights to Alder’s clazakizumab, which showed promising Phase 2 data in 2013 as a rheumatoid arthritis treatment. A BMS spokesperson told Xconomy the decision was … Next Page »

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AbbVie Plunks Down $275M Upfront for Infinity’s Blood Cancer Drug

Wed, 09/03/2014 - 08:56
Ben Fidler

It’s been a topsy-turvy few years for Infinity Pharmaceuticals. The Cambridge, MA-based company is well behind a few others, whose rival blood cancer drugs that have already made it to market, and Infinity has seen its shares rise and fall as investors have wondered whether its own prospect—known as duvelisib, or IPI-145—can stand out.

Pharma giant AbbVie, however, appears to believe it has a shot.

Today, Infinity (NASDAQ: INFI) has announced a big deal with AbbVie (NYSE: ABBV), which has agreed to shell out as much as $805 million to help the Massachusetts biotech get its drug through clinical development.

AbbVie will pay Infinity $275 million up front to grab rights to duvelisib, and has attached another $530 million in potential milestones to the deal. In return—assuming duvelisib makes it through clinical development and wins FDA approval—the two companies will co-commercialize duvelisib and share U.S. profits. Outside the U.S., AbbVie will own rights to the drug and will cover commercialization costs, with Infinity getting royalties on net sales ranging from 23.5 percent to 30.5 percent.

Inifinity will fund the trials it conducts, while the two companies will equally share the costs in the trials run by AbbVie. The two aim to run several mid- and late-stage trials testing duvelisib over the next several years in a variety of blood cancers. Duvelisib is currently in Phase 3 testing for patients with relapsed/refractory chronic lymphocytic leukemia (CLL), with another Phase 3 study testing duvelisib in tandem with rituximab (Rituxan) in follicular lymphoma expected to begin later this year. Infinity is also running a Phase 1 trial for duvelisib in patients with other advanced blood cancers as well.

Wall Street is cheering the news this morning. Infinity shares are up more than 40 percent in pre-market trading.

Duvelisib is one of several so-called PI3 kinase inhibitors, one of the hottest fields in biology for many years now. Targets in the PI3 kinase pathway are implicated in a bunch of important molecular functions, like cell survival and proliferation. The first generation of PI3 kinase drugs blocked the whole pathway, leading to a number of unwanted side effects, but more recent drugs, like Gilead Sciences’ idelalisib, and Infinity’s duvelisib, were developed more selectively—to hit certain variations of PI3 kinase instead.

That strategy, as well as a number of other advances, has led to significant progress in treating blood cancers like CLL. Sunnyvale, CA-based Pharmacyclics (NASDAQ: PCYC), for instance, won FDA approval earlier this year of a drug called ibrutinib (Imbruvica) that binds to a different molecular target called bruton’s tyrosine kinase. Ibrutinib has since gone on to become a massive-selling drug. Foster City, CA-based Gilead (NASDAQ: GILD) followed with an FDA nod for idelalisib (Zydelig) in CLL in July. Even AbbVie has a competitor looming dubbed ABT-199.

Infinity’s biggest problem has been trying to stand out in the crowd, and the result has been a roller coaster on Wall Street. Shares were as low as $5.98 apiece in 2012, then climbed to more than $35 in early 2012, before rolling back downhill as Gilead and Pharmacyclics’ drugs have made it through clinical development first, with nothing seemingly giving duvelisib a distinct edge. Shares closed Tuesday at just $10.92.

While it’s unclear at this point just where Infinity’s drug will fit into the crowded field, AbbVie is showing today that it believes duvelisib will find a niche.

“We believe that duvelisib is a very promising investigational treatment based on clinical data showing activity in a broad range of blood cancers,” said AbbVie executive vice president and chief scientific officer Michael Severino. “The addition of duvelisib will complement AbbVie’s emerging oncology pipeline and expand our research into combination therapies to generate improved outcomes for cancer patients. We look forward to working with Infinity to bring duvelisib to patients worldwide.”

RBC Capital Markets analyst Michael Yee added in a note to investors this morning that the AbbVie deal puts “a stamp of validation” on Infinity.

Infinity first acquired duvelisib by licensing the drug from San Diego, CA-based Intellikline, which was acquired by Takeda in 2011. Infinity has an obligation to pay part of its royalty stream to Takeda as a result of the deal.

Infinity will hold a conference call later this morning discussing the deal.

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Feds Provide Funding, Expertise to Advance ZMapp Drug for Ebola

Tue, 09/02/2014 - 22:37
Bruce V. Bigelow

The U.S. Department of Health and Human Services said today it would provide its expertise and as much as $42.3 million to help San Diego-based Mapp Biopharmaceutical accelerate development and testing of ZMapp, the biotech’s experimental Ebola drug.

With just nine employees, Mapp Bio lacks the resources to respond to the Ebola crisis unfolding in Western Africa, co-founder and CEO Kevin Whaley said at an event last week in San Diego. The biotech, founded in 2003 to address the public health needs of mothers and children in developing countries, was looking for government help, Whaley said.

In a statement today, the federal health agency said it would provide $24.9 million to Mapp Bio through an initial, 18-month contract. The company will make a small amount of ZMapp for early stage clinical safety studies and for non-clinical animal studies needed to demonstrate its safety and effectiveness.

The effort is intended to advance ZMapp toward FDA approval, and includes subject-matter expertise and technical support to accelerate drug manufacturing and to address regulatory and other non-clinical concerns. The health agency’s assistant secretary for preparedness and response can extend the contract up to a total of $42.3 million.

There are no approved vaccines or drugs for treating Ebola. The NIH was expected to begin human safety trials this week on a vaccine that was co-developed with GlaxoSmithKline, this week, and a second trial is set to begin in October under the auspices of the National Institute of Allergy and Infectious Diseases.

The virus causes flu-like symptoms, including a headache and fever, then escalates to vomiting, diarrhea, and bleeding. Scientists say the virus replicates so rapidly that a patient’s immune system is basically in a race against death.

The strain responsible for the outbreak in West Africa has killed about half of the 3,069 suspected and confirmed cases of Ebola in four countries: Guinea, Liberia, Nigeria, and Sierra Leone. The World Health Organization warned last week that the virus could infect as many as 20,000 people before it can be brought under control.

Mapp Bio was working in relative obscurity before the Ebola outbreak in West Africa went from a public health emergency to a global health crisis. Tom Frieden, the director for the Centers of Disease Control and Prevention, said that in recent weeks the outbreak has become the world’s first Ebola epidemic, and it is “spiraling out of control.”

ZMapp combines three antibodies that bind to proteins on the Ebola virus. Scientists believe that the antibodies, which are produced in the leaves of tobacco plants, prevent the virus from entering human cells to replicate and trigger an immune response that destroys the viruses.

The drug had never been tested in humans, but Mapp Bio provided all of the available samples of ZMapp it had produced earlier this year for the emergency treatment of seven healthcare workers in West Africa. Four people who received the drug survived, including the American missionaries Kent Brantley and Nancy Writebol. But two others died.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” said Dr. Nicole Lurie, the Department of Health and Human Services’ assistant secretary for preparedness and response.

On Friday, scientists reported that in one preclinical trial, ZMapp had cured all 18 lab monkeys infected with Ebola, including those suffering fever and hemorrhaging that were hours from death.

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Measurabl Raises $2M to Provide Various Disclosures as a Service

Tue, 09/02/2014 - 19:55
Bruce V. Bigelow

Measurabl, a San Diego startup developing Web-based software to help big companies and others collect data required to meet non-financial disclosure requirements, says today it has raised $2 million in a seed funding round led by CrossCut Ventures.

The startup was founded last year by Matt Ellis, who was previously director of sustainability solutions at CBRE (NYSE: CBG), the commercial real estate company based in Los Angeles. At CBRE, Ellis saw how companies often struggled to collect and report data about their own energy and water use, carbon dioxide emissions, and waste production.

“The pain point in the market is that there are so many different formats for how this data should be disclosed,” Ellis says. In addition to state and federal regulatory requirements in the United States, Ellis says many companies face a different set of disclosure requirements for their operations in Europe and other countries.

Ellis says he founded Measurabl almost 17 months ago to provide a way to collect and organize data for customers, and to submit such information in the format required by various regulatory agencies. The company plans to use the funding to advance its software development, Ellis says. Measurabl currently has 10 employees.

The startup also is developing its Web-based software to collect and report “social” data on such topics as consumer protection, human rights, and diversity, as well as for issues related to corporate governance. Some socially responsible investment groups require certain disclosures to avoid making investments in companies with businesses involved in such issues as alcohol, tobacco, gambling, pornography, abortion, and weapons.

“A lot of companies are being forced into these types of disclosure activities,” Ellis says.

The company says its TurboTax-style wizards make it easier for companies to document, report, assess, and improve their operations with regard to environmental sustainability, social issues, and ethical corporate conduct.

Measurabl began by helping clients use the industry-driven Global Real Estate Sustainability Benchmark (GRESB) to assess how well real estate portfolios meet environmentally sustainable standards for performance. The company tested its software through pilot programs with customers last year before releasing it commercially this year. Customers include Clarion Partners, CBRE Global Investors, and TA Realty.

The startup first aims to serve real estate investment trusts and big retail developers that have portfolios of commercial buildings. Over time, Measurabl plans to broaden its market to include companies generating at least $1 billion in revenue, along with large municipalities and government agencies.

Measurabl says a few small companies, such as OneReport and EcoVadis, compete in certain niche markets, while SAP, Oracle, and other big software companies offer comprehensive platforms that are more expensive.

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Which Countries Excel in Creating New Drugs? It’s Complicated

Tue, 09/02/2014 - 04:00
Stewart Lyman

A lot has been written lately about innovation, or the lack thereof, in the world of biopharma. One question that often gets asked: which countries lead the way in creating new medicines? Many people think that drugs originate in the nation where the companies that produce them are headquartered. The truth, however, is much more complicated. Given that multi-national firms market the majority of medicines, figuring out where each one of their drugs originated requires digging through some extensive data vaults. A proper analysis requires the examination of company histories, free market deal making, and in some cases government interventions. Consider the following examples:

Roche is headquartered in Basel, so you might think that all of its drugs are created in Switzerland. Actually, many of Roche’s biggest blockbusters were born in the USA at Genentech, its South San Francisco based subsidiary. Roche’s acquisition of Genentech (initiated in 1990 and completed in 2009) has been a transformative driver of the company’s success in recent years. It led Roche to abandon the PhRMA trade group in favor of BIO, and to rebrand of many of its drugs from having the Roche imprint on the label to Genentech.

Sanofi is located in Paris, so its drugs originate in France, right? Many do, but with its acquisition of Boston-based Genzyme and more recent business deals with Tarrytown, NY-based Regeneron Pharmaceuticals (NASDAQ: REGN) and Cambridge, MA-based Alnylam Pharmaceuticals (NASDAQ: ALNY), much of the company’s R&D work is now happening here in the U.S. Want evidence for the importance of this American connection? Chris Viehbacher, Sanofi’s German-Canadian CEO, has actually moved from Paris to Beantown.

Pfizer’s corporate offices are located in New York City and its largest R&D facilities are in Connecticut, so its drugs are clearly made in America. Or are they? One of Pfizer’s biggest-selling drugs, sildenafil (Viagra), originated in its labs in Sandwich, England. If Pfizer had (or does) successfully acquired AstraZeneca and relocated the company’s headquarters to London for tax purposes, would all of its drugs suddenly become British?

Valeant Pharmaceuticals (NYSE: VRX), a U.S. based pharma company, became Canadian when it was acquired by Biovail back in 2010. The merged company adopted the Valeant name. Now Canadian Valeant is making an effort to acquire California-based Allergan (NYSE: AGN). Will Allergan’s drugs be required to make the long drive north on I-5 and cross the border if Valeant is successful with its bid?

The innovation and country of origin story gets even more complicated. Sometimes a company’s headquarters don’t change as a result of a merger, but its tax status can migrate to another country. U.S.-based Auxilium Pharmaceuticals (NASDAQ: AUXL) is planning to merge with Canada’s QLT. The combined company’s headquarters will remain in the U.S., but because of the 24 percent Canadian stake, the “New Auxilium’s” tax rate will drop from 35 percent (the U.S. rate) to Canada’s 15 percent rate. The deal will only happen if the combined company will “not be treated as a U.S. domestic corporation for U.S. federal income tax purposes.” Would this make the New Auxillium’s drugs Canadian, or will they be American? And will QLT’s products now be considered to be from the U.S.? Similarly, Chicago based AbbVie has recently acquired Ireland’s Shire with a similar “tax inversion” in mind, although the actual tax savings from this hookup have been called into question.

Let’s dive in a little deeper. Consider the data in the table below (from the Milken Institute report, The Global Biomedical Industry: Preserving U.S. Leadership). The table purports to show how the number of drugs produced within certain countries has changed over time. The take home message: drug discovery efforts have moved in large part from Europe and Japan to the U.S. over the past 30 years. But these numbers are difficult to interpret due to the frequent acquisition of both companies and products during this time period.

 

The percentage of all NCE’s (New Chemical Entities) that originated from U.S.-based companies rose from about 31 percent in the ‘70s and ‘80s to 42 percent in the ‘90s to 57 percent in the 2000s. These data raise three important questions:

1) Are the data reliable? I would argue that these numbers are questionable due to the fact that pharmaceutical companies migrate often (and therefore the place where “innovation” occurs moves as well) as a result of mergers, acquisitions, and relocations.

2) Does the apparent increase in the percentage of drugs discovered in the U.S. simply … Next Page »

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Mapp Bio Steps onto Global Stage as Ebola “Hot Zone” Gets Hotter

Fri, 08/29/2014 - 01:01
Bruce V. Bigelow

The “hot zone” in West Africa that has become the worst Ebola outbreak in history is now a full-blown global health crisis—and it is expected to continue into 2015.

That is the consensus of three Ebola experts who, speaking at a public forum in San Diego, joined a growing number of world health officials in warning that the thousands of known and suspected Ebola cases may be just the beginning in a protracted battle to bring the letal viral contagion under control.

The forum, held in a lobby of The Scripps Research Institute (TSRI) Wednesday, included a rare public appearance by Kevin Whaley, CEO of Mapp Biopharmaceutical, the tiny San Diego biotech that developed ZMapp, the experimental anti-viral drug given to American missionaries Kent Brantly and Nancy Writebol, as well as a Spanish priest and three African healthcare workers—who were all stricken with Ebola. One of the African healthcare workers, Dr. Abraham Borbo of Liberia, and the Rev. Miguel Pajares of Madrid, nevertheless succumbed to the disease.

Whaley, who has avoided the celebratory publicity surrounding ZMapp, said he and co-founder Larry Zeitlin “both came out of the school of public health at Johns Hopkins,” and founded Mapp Bio in 2003 to serve the “unmet needs in global health.” The company has only nine employees and is focused primarily on the health needs of mothers and children in “under-funded and under-appreciated” places like West Africa.

Kevin Whaley

The unassuming Whaley declined to say much about his feelings after Brantly and Writebol walked out of the Emory University Hospital in Atlanta, where they were hospitalized after receiving the first doses of ZMapp ever administered to humans. While the experience was “certainly very satisfying,” Whaley said ZMapp was not given in a way that could yield any scientifically validated data or conclusions. “Any skeptical scientist would have to say there is no way to know” whether the drug contributed to the four survivors’ recovery, he said.

With all available samples of ZMapp now exhausted, Whaley said Mapp Bio is looking for major help from the federal government to make more.

Meanwhile, the World Health Organization said Thursday the Ebola outbreak could infect more than 20,000 people before it is over. Tom Frieden, director of the Centers for Disease Control and Prevention (CDC), told CNN Wednesday that the situation in Liberia is worse than he expected. Because Ebola symptoms can take weeks to develop, Frieden said the risk of exporting Ebola to another country increases every day the outbreak goes on.

Health authorities have counted 1,552 deaths in at least 3,069 suspected or confirmed Ebola cases since the outbreak began at the beginning of this year, according to an update posted on the CDC website Thursday. The disease has spread to four countries in West Africa: Sierra Leone, Liberia, Guinea, and Nigeria. As the crisis mounts, the U.S. and U.K. are finally moving to test a new Ebola vaccine for the first time in … Next Page »

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